BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1042787 · Received May 8, 2008

    Report

    Report Number
    2124215-2008-33846
    Event Type
    Injury
    Date Received
    May 8, 2008
    Date of Event
    February 21, 2008
    Report Date
    February 21, 2008
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0185 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention THE DEVICE 4469/493467 WAS IMPLANTED 21-FEB-2008| THE DEVICE 4548/155347 WAS IMPLANTED 21-FEB-2008| THE DEVICE H210/215822 WAS IMPLANTED 20-DEC-2007| THE DEVICE 4469/490511 WAS IMPLANTED 20-DEC-2007| THE DEVICE 4542/122397 WAS IMPLANTED 20-DEC-2007